Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
2. 2
Forward Looking Statement
These forward-looking statements relate to future events or future financial performance of the
Company. All such forward-looking statements involve risks and uncertainties and are not guaranties
of future performance. An investment in the securities of Aridis is speculative in nature, involves a
high degree of risk, and should not be made by an investor who cannot bear the economic risk of its
investment for an indefinite period of time and who cannot afford the loss of its entire investment.
These include many important factors that affect our ability to achieve our stated objectives including,
but not limited to:
* The timing of regulatory submissions;
* Our ability to obtain and maintain regulatory approval of our existing product candidates and any
other product candidates we may develop, and the labeling under any approval we may obtain;
* Approvals for clinical trials may be delayed or withheld by regulatory agencies;
* Pre-clinical and clinical studies will not be successful or confirm earlier results or meet expecta-
tions or meet regulatory requirements or meet performance thresholds for commercial success;
* The timing and costs of clinical trials, the timing and costs of other expenses;
* Our ability to obtain funding from third parties;
* Management and employee operations and execution risks;
* Loss of key personnel;
* Competition;
* Market acceptance of products;
* Intellectual property risks;
* Assumptions regarding the size of the available market, benefits of our products, product pricing,
timing of product launches;
* The uncertainty of future financial results;
* Risks associated with this offering;
* Our ability to attract collaborators and partners;
* Our reliance on third party organizations.
We operate in a very competitive and rapidly changing environment. New risks emerge from time to
time. It is not possible for our management to predict all risks, nor can we assess the impact of all
factors on our business or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking statements we may make. In
light of these risks, uncertainties and assumptions, the forward-looking events and circumstances
discussed in this presentation may not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking statements.
Except as required by law, neither we nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements. We undertake no obligation to update publicly
any forward-looking statements for any reason after the date of this presentation to conform these
statements to actual results or to changes in our expectations.
We have filed a registration statement (including a prospectus) with the Securities and Exchange
Commission ("SEC") for the offering to which this communication relates. Before you invest, you
should read the prospectus in the registration statement and other documents we have filed with the
SEC for more complete information about us and this offering. You may get these documents for free
by visiting EDGAR on the SEC web site at http://www.sec.gov. Alternatively, we, any underwriter, or
any dealer participating in the offering will arrange to send you the prospectus if you request it from
Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY
10022; email: prospectus@cantor.com. This presentation shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.
3. 3
Targets IND
Pre-Clinical
Products Phase 2
Phase 1 Phase 3
Gram (+) Bacteria
S. aureus a-toxin
Pneumonia & Blood Stream Infections
HAP/VAP
Cystic Fibrosis
COVID-19
Gram (-) Bacteria
P. aeruginosa LPS O11
Gram (-) & (+)
Iron Acquisition Systems
COVID-19
AR-301 mAb
(Salvecin)
AR-101 mAb
(Aerumab)
AR-501
(Panaecin)
AR-712 mAb
AR-701
Bacteremia
A. baumannii
AR-401 mAb
Product Pipeline
Next
Milestone
Interim Futility
data 2H2021
Phase 2/3
tbd
Phase 2a data
2H2021
Phase 1/2
2H2021
IND
4Q2022
Gram (-) Bacteria
RBD mAb
5. 5
3
0
Months
6 9 12 15 18 21 24 27
TRADITIONAL: Discovery, Development, and Manufacturing
APEX TM
Discovery, Development, and Manuf. 12-15 months time saving
Convalescent
COVID-19 patient
B-cell
Selected
Cloned CDRs
or H&L of IgG’s
APEX TM
Nanoarrays
B-cell
repertoire screening
B.R.E.A.T.H. TM
CHO cell line
CRISPR
Guided Integration
GMP
Manufacturing
λPEX Monoclonal Antibody Discovery and
Production Platform Technology
6. 6
Kyaw MH et al., 2015 BMC Health Serv Res. 15:241
Restrepo (2010) ICHE 31:509-515
Hospital Days
7.2
60 days
40 days
20 days
$220,000
$110,000
Control Staph Pseudomonas Control Staph Pseudomonas
37.9
55.4
$33,851
$146,978
$213,104
In-Patient Costs
ICU stay
All Cause
Mortality
1.1 day 6.9 days 14.8 days
3% 16% 20%
1.1 day 6.9 days 14.8 days
3% 16% 20%
~252,000 ICU patients
US claims database (2018)
n=201 n=394
Healthcare Burden: S. aureus and P. aeruginosa Bacteria
Hospital 44.4%
%
0
.
1
2
y
c
a
m
r
a
h
P
%
3
.
6
1
y
r
o
t
a
r
o
b
a
L
Respiratory Treatment (Mech. ventilation) 9.3%
Radiology (+CT Scans) 3.3%
%
9
.
1
y
g
o
l
o
i
d
r
a
C
Operating Room 1.4%
Diagnostics (Blood ECG) 1.9%
Pulmonary Diagnostic 0.4%
%
3
.
0
c
i
d
a
e
p
o
h
t
r
O
Survey of 30 cases (median)
7. 7
Normal Alveolus
PMN
Macrophages
α-toxins
α-toxins
Staphylococcus aureus
Staphylococcus aureus
Targets S. aureus α-Toxin
Necrosis
Alveolar
air space
Type 1 cells
Interstitium
Anti-toxin monoclonal
antibody approach is a
proven MOA, e.g.
Anthrax mAb Raxibacumab (GSK-EBSI)
S. Aureus mAb MEDI4893 (AZN)
Intact
Immune Cell
Gram (+) bacteria: S. aureus
mAb
α-toxins attacking
immune cell
Red blood cells
Neutrophils
Macrophages, Monocytes
Toxins 2013, 5(6), 1140-1166
T-cells
Pneumoncytes
Endothelial cells
AR-301 Mechanism of Action:
Host cells killed by α-toxins
Commercialized
Under development
8. 8
Antibiotics-alone Adjunct therapy
Standard
of Care
Standard
of Care
AR-301
Superiority Trial Design
VS.
With positive data, provides for value-based premium reimbursement
Therapeutic Treatment in Acute Pneumonia Setting
9. 9
Randomized, double-blind, placebo-controlled, single ascending dose of AR-301
31 sites across EU and U.S.
SOC [antibiotics alone] + Placebo n=16
SOC + AR-301 (1 mg/kg ) n= 6
SOC + AR-301 (3 mg/kg) n= 8
SOC + AR-301 (10 mg/kg) n=10
SOC + AR-301 (20 mg/kg) n= 8
48 patients with HAP or VAP caused by S. aureus
Safety and pharmacokinetics
Data trend in favor of adjunctive treatment benefit
Time to removal of ventilator (VAP patients)
Microbiological cure
Shorter time to eradication
Days in ICU
Design
Patient Selection
Groups
Primary Endpoint
Secondary Endpoint Hospitalization days
All-cause mortality
Clinical cure rate
AR-301 Phase 2: Trial Recently Completed
10. 10
Antibiotic
Half Life
20 mg/kg
(hours) Time since start of infusion
50% (half-life mark)
Mean
Plasma
Concentration
24 48 72 96 120 144 168
0
ug/mL
200
ug/mL
400
ug/mL
600
ug/mL
Adjunctive AR-301 treated groups were well
antibiotics alone (placebo) group (n=48).
Few adverse events (AEs) deemed related to
AR-301 (2.8%).
No serious adverse events (SAEs) related to
AR-301.
Deaths were deemed unrelated to AR-301
treatment (n=6).
(plasma half-life of 23-31 days)
AR-301
AR-301: Favorable Phase 2 Safety & PK Data
11. 11
Probability
of
Receiving
Mechanical
Ventilation
Days on Mechanical Ventilators
+AR-301 Pooled (n=20)
Antibiotics alone (n=5)
5 10 15 20 25
100%
80%
60%
40% 40%
50%
improvement
20%
Probability
of
Receiving
Mechanical
Ventilation
0
Francois, B. et al. 2018 Intensive Care Medicine.
Aggregated AR-301 treated VAP groups
exhibited lower probability of requiring
mechanical ventilation vs. placebo.
Phase 2
12. 12
1-to-1 randomized,
double-blind,
placebo-controlled, single
dose IV infusion
Enrolling 240 patients with
VAP caused by S. aureus
across 125 sites in 20
countries (U.S., EU, Asia)
Evaluating the potential of
adjunctive AR-301 (20 mg/kg)
to SOC antibiotics vs.
antibiotics alone
Primary endpoint of clinical
cure rate at day 21
Interim futility analysis of 120 patients
readout in 1H2022
Test of
Clinical
Cure
Randomize
& Treat
infusion
AR-301 at 20 mg/kg
IV infusion
n = 120
Day 21
n = 120
Broad
spectrum
antibiotics
Broad
spectrum
antibiotics
(ClinicalTrials.gov ID NCT03027609)
AR-301 Phase 3: Trial Design
in 2H2021 and final data
13. 13
Powering Calculation and Assumptions
n = 240 enrollment target
over-powered to achieve
superior clinical cure rate
p<0.05
** Rationale for 20% absolute
clinical cure rate improvement setting
Considered clinically meaningful to physicians
Ph2a data showed trend toward improvements in
shorter ventilation time & microbiological eradication
(i.e. 2 of the 3 components of the primary endpoint)
AR-301 Phase 3 Study
Study
Power
80%
90%
75%
75%
95%
95%
20%
20%
n = 55
n = 69
n = 110
n = 138
Control
(SOC)*
AR-301
+ SOC
Absolute
**
Evaluable
per group
Total
Enrolled
Primary Endpoint: Clinical Cure Rate
14. 14
Sources
Potential S. aureus HAP/VAP Patients by Market
395,000 Patients in the US, Japan, EU
Gram (+) Staphylococcus aureus-Induced HAP/VAP
Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus
Estimated $6 billion annual healthcare cost burden attributable to
S. aureus nosocomial pneumonia
Breakdown
of Strains 48%
52%
1 DR/Decision Resources, LLC. 2016;
2 Chastre J, and Fagon J-Y, Ventilator-associated pneumonia, State
of the Art, Am J Respir Critical Care Med, 2002 (165): 867-903.
3 Warren DK, Outcome and Attributable Cost of VAP among ICU
patients in a suburban medical center,
Critical Care Med 2003;31(5):1312-7.
MRSA
MSSA
90,000
251,600
U.S.A.
Japan
53,700
Europe
$6 Billion Market for (AR-301): VAP, HAP
15. 15
SOC antibiotics in HAP/VAP:
Avycaz / ceftazidime/avibactam (AstraZeneca): $13,764 (14 days course)
Vibativ/ Telavancin (Astellas): $8,841 (21 days course)
Pneumonia caused by MRSA
$1,000
AR-301 Product Contribution
Key Assumptions
First-line adjunctive treatment
MRSA only HAP / VAP / HCAP
60% marketshare
US / EU / Japan
$10,500 per course
$Million
(Net
of
Expenses)
$800
$600
$400
$200
$00
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034
1st Phase 3 2nd Phase 3 BLA & Launch
16. 16
AR-301
Pre-Emptive Treatment In S. Aureus Colonized Patients Also Show Evidence
of Clinical Benefits
At-risk (non-infected)
Asymptomatic
Lung colonized, High risk
Asymptomatic
Decreased risk of VAP 32%
Decreased risk of VAP 47% (<65 yrs old)
Full-on lung infection
Ventilator-assoc. pneumonia
Prophylactic
AstraZeneca’s
Suvratoxumab
Pre-emptive
Phase 2 Results (n=196)*:
[data 1H2022]
Phase 3 (n = 240)
Treatment for Acute
AR-301 Data: Proxy Data from AZN’s Suvratoxumab
17. 17
AR-501: Novel Inhaled Non-Antibiotic
Mechanism of Action
Small Molecule Anti-infective
Iron (Fe) is necessary for bacterial metabolic
functions. AR-501 (gallium, Ga) replaces Fe
AR-501 impairs mulitple bacterial functions
Standard antibiotics inhibit single targets
Ga
Gallium
18. 18
PARI eFlow
nebulizer
AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
Phase 1 Healthy Volunteers
(1H-2019) Single Ascending Dose
6 mg
18 patients 6 patients
20 mg
AR-501
Done
AR-501
Placebo
18 patients 6 patients
Placebo
40 mg
6 mg 20 mg 40 mg
(1H-2020) Multiple Ascending Doses
t = 0, 1, 2, 3, 4 weeks
Done AR-501
30 patients 15 patients
Placebo
6 mg 20 mg 40 mg
(2H-2021) Multiple Ascending Doses
t = 0, 1, 2 weeks
Phase 2 Cystic Fibrosis Patients
Primary Endpoint:
Safety and PK
Secondary Endpoints:
Lung function of CF patients
(changes in FEV1)
Sputum bacteriology
Data Readout:
Phase 2a CF subjects in 2H2021
CF Foundation Funded
Ph1 study results: AR-501 was well tolerated
19. 19
Sputum
concentration
mg/mL
300
IV
Inhaled
(est.)
2
Gallium
Gallium
Placebo
Placebo
1
10%
8%
6%
4%
2%
0%
-2%
-4%
-6%
6 14 28 56
60 60 58 60 59
59 57 57 56 56
Day Days Days Days Days
Patients Patients Patients Patients Patients
Mean
Relative
Change
from
Baseline
FEV
(L)
Intent to Treat Population CF Patients
Inhaled
Delivery
A single IV dose of gallium resulted in statistical
significant improvement in lung infection
Data from University of Washington: Goss, C. et al. 2018
N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data)
Safety & Efficacy
of IV Gallium
Demonstrated
Proxy Data:
20. 20
*UK, So. Africa, Brazil, Japan SARS-CoV-2 strains
AR-712 two mAbs cocktail bind to COVID’s
spike protein, blocking COVID & its
variants* from being able to bind
to the host cell.
AR-712: Inhaled COVID-19 mAb Program
Highly potent SARS-CoV-2 fully human mAbs from convalescent COVID-19 patients
- Proprietary stable inhaled formulation designed for direct lung delivery
- Therapeutically eradicated SARS-CoV-2 at ultra low dose (~0.05 mg/kg) in
animal challenge model
- Up to year-long protection (engineered for plasma half-life extension)
- Engineered removal of antibody disease enhancement (ADE) risk
AR-712
LLY (CoV555)
REGN (10933/10987)
>1,000x
2 - 6 mg (est)
700 to 7,500 mg
2,400 to 8,000 mg
AR-712 in-human dosing is the lowest vs. all competitors*
*Scaling to human dose based on animal SARS-CoV-2 challenge study. See https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1
21. 21
AR-712: Inhaled COVID-19 mAb Program
Convenient self-dosing in-home
Target Populations
- Designed to lower the barrier to COVID-19 treatment in outpatients
- Treatment mild to moderate COVID-19 non-hospitalized patients
- Prophylaxis [elderly, high risk frontline workers, etc]
Phase 1/2 in 2H21
Phase 3 data in 2022
https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1.
23. 23
Vu Truong
CEO, Director
(Formerly Medimmune, Aviron)
Michael Nazak
Chief Financial Officer
(Formerly Coherus, intekrin)
Steve Chamow
VP, Development
(Formerly Genentech, Abgenix)
Hasan Jafri
Chief Medical Officer
(Formerly AstraZeneca/Medimmune)
Elizabeth Leininger
VP, Regulatory
(Formerly FDA, Novartis)
Mitch Rosner
VP, Quality
(Formerly Synthetic Gen., IDEC)
Lynne Deans
VP, Clinical Operations
(Formerly Roche, Dermira)
Senior Management
24. 24
Eric Patzer, Ph.D.
Director, Chairman
(Co-Founder, Aridis)
Robert Ruffolo, Ph.D., D.Sc.
Director
(Former President Wyeth/Pfizer)
Craig Gibbs, Ph.D., M.B.A.
Director
(Commercial Gilead; Genentech)
John Hamilton, M.B.A.
Director
(CFO, Depomed; BioMarin)
Susan Windham-Bannister, Ph.D.
Director
(Assoc. Women in STEM, Mass. Life Sci. Ctr)
Vu Truong, Ph.D.
Director
(CEO, Aridis)
Board of Directors
25. 25
Financial Information
Condensed Consolidated Statement of Operations
Three Months
Ended
09/30/2020
($ in 000’s)
Total revenue $1,000
Research and development $4,161
General and administrative $1,631
Loss from operations $(5,792)
Net loss $(5,786)
Balance Sheet
As of
Sept. 30, 2020
Cash and cash equivalents (excludes ~$8.5m Oct. 2020) $6,212
Common stock:
100,000,000 shares authorized;
8,923,374 shares issued and outstanding as of September 30th, 2020
Analyst Coverage ($18 - $22 PT)
- Cantor Fitzgerald (Louise Chen)
- HC Wainwright (Vernon Bernadino)
- ROTH Capital (Jonathan Aschoff)
- Maxim Group (Jason MacCarthy)
- Northland Securities (Carl Byrnes)
- Laidlaw (Frank Brisebois)